Prescription medicine
Cabozantinib Brand names: Cabometyx, Cometriq
Cabozantinib (Cabometyx) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the cabozantinib FDA label on DailyMed (effective October 19, 2025, Exelixis, Inc.); the NDA 203756 record on Drugs@FDA; every cabozantinib label on DailyMed.
Highlights of the record
FDA label of October 19, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
Forms and strengths
- 20 mg
- 40 mg
- 60 mg
Tablet; kit; capsule.
On the market
- Earliest approval on file
- November 29, 2012 Cometriq, Exelixis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first August 14, 2026; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 9, 2033 Cabometyx tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 47,766 through July 30, 2026
What is cabozantinib used for?
From the label: indications and usageCABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (CABOMETYX), Exelixis, Inc., effective October 19, 2025 (SPL set 3850cce2-6137-42e5-a792-d318c4a4b3b5), via openFDA; the full label on DailyMed
What does the patient leaflet for cabozantinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking CABOMETYX?Avoid drinking grapefruit juice, eating grapefruit or taking supplements that contain grapefruit or St. John’s wort during treatment with CABOMETYX.
From the patient leaflet: How should I store CABOMETYX?Store CABOMETYX at room temperature between 68°F to 77°F (20°C to 25°C). Keep CABOMETYX and all medicines out of the reach of children.
Source: FDA drug label (CABOMETYX), Exelixis, Inc., effective October 19, 2025 (SPL set 3850cce2-6137-42e5-a792-d318c4a4b3b5), via openFDA; the full label on DailyMed
Is there a generic for cabozantinib (Cabometyx)?
The FDA approved the first generic cabozantinib on August 14, 2026. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 10 patents for Cabometyx tablets: the compound patent runs to October 8, 2030, and the last listed entry to July 9, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2026 first generic approved
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the cabozantinib label say about other medicines?
The cabozantinib label names 21 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name cabozantinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abacavir | drug interactions | Monitor patients for increased toxicity when MRP2 inhibitors (e.g., abacavir, adefovir, cidofovir, furosemide, lamivudine, nevirapine, ritonavir, probenecid, saquinavir, and tenofovir) are co-administered with COMETRIQ [see Clinical Pharmacology ( 12.3 )]. |
| Atazanavir | drug interactions | Avoid taking a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) while taking COMETRIQ or reduce the dosage of COMETRIQ if concomitant use with strong CYP3A4 inhibitors cannot be avoided [see … |
| Carbamazepine | drug interactions | Avoid chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John’s Wort) with COMETRIQ or increase the dosage of COMETRIQ if concomitant use with strong CYP3A4 inducers cannot be avoided [see Dosage and Administration ( 2.2 ), Clinical … |
| Cidofovir | drug interactions | Monitor patients for increased toxicity when MRP2 inhibitors (e.g., abacavir, adefovir, cidofovir, furosemide, lamivudine, nevirapine, ritonavir, probenecid, saquinavir, and tenofovir) are co-administered with COMETRIQ [see Clinical Pharmacology ( 12.3 )]. |
| Clarithromycin | drug interactions | Avoid taking a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) while taking COMETRIQ or reduce the dosage of COMETRIQ if concomitant use with strong CYP3A4 inhibitors cannot be avoided [see … |
| Furosemide | drug interactions | Monitor patients for increased toxicity when MRP2 inhibitors (e.g., abacavir, adefovir, cidofovir, furosemide, lamivudine, nevirapine, ritonavir, probenecid, saquinavir, and tenofovir) are co-administered with COMETRIQ [see Clinical Pharmacology ( 12.3 )]. |
| Itraconazole | drug interactions | Avoid taking a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) while taking COMETRIQ or reduce the dosage of COMETRIQ if concomitant use with strong CYP3A4 inhibitors cannot be avoided [see … |
| Ketoconazole | drug interactions | Administration of a strong CYP3A4 inhibitor, ketoconazole to healthy subjects increased single-dose plasma cabozantinib exposure by 38%. |
| Lamivudine | drug interactions | Monitor patients for increased toxicity when MRP2 inhibitors (e.g., abacavir, adefovir, cidofovir, furosemide, lamivudine, nevirapine, ritonavir, probenecid, saquinavir, and tenofovir) are co-administered with COMETRIQ [see Clinical Pharmacology ( 12.3 )]. |
| Nefazodone | drug interactions | Avoid taking a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) while taking COMETRIQ or reduce the dosage of COMETRIQ if concomitant use with strong CYP3A4 inhibitors cannot be avoided [see … |
| Nelfinavir | drug interactions | Avoid taking a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) while taking COMETRIQ or reduce the dosage of COMETRIQ if concomitant use with strong CYP3A4 inhibitors cannot be avoided [see … |
| Nevirapine | drug interactions | Monitor patients for increased toxicity when MRP2 inhibitors (e.g., abacavir, adefovir, cidofovir, furosemide, lamivudine, nevirapine, ritonavir, probenecid, saquinavir, and tenofovir) are co-administered with COMETRIQ [see Clinical Pharmacology ( 12.3 )]. |
| Nivolumab | warnings and precautions | When used in combination with nivolumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur than with CABOMETYX alone. |
| Phenobarbital | drug interactions | Avoid chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John’s Wort) with COMETRIQ or increase the dosage of COMETRIQ if concomitant use with strong CYP3A4 inducers cannot be avoided [see Dosage and Administration ( 2.2 ), Clinical … |
Every other medicine the cabozantinib label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenytoin | drug interactions | Avoid chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. … |
| Probenecid | drug interactions | Monitor patients for increased toxicity when MRP2 inhibitors (e.g., abacavir, adefovir, cidofovir, furosemide, lamivudine, nevirapine, ritonavir, probenecid, saquinavir, and tenofovir) are … |
| Rifabutin | drug interactions | Avoid chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. … |
| Rifampin | drug interactions | Administration of a strong CYP3A4 inducer, rifampin to healthy subjects decreased single-dose plasma cabozantinib exposure by 77%. |
| Rifapentine | drug interactions | Avoid chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. … |
| Ritonavir | drug interactions | Avoid taking a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) while … |
| Voriconazole | drug interactions | … indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) while taking COMETRIQ or reduce the dosage of COMETRIQ if concomitant use with strong CYP3A4 inhibitors cannot … |
Source: FDA drug label (CABOMETYX), Exelixis, Inc., effective October 19, 2025 (SPL set 3850cce2-6137-42e5-a792-d318c4a4b3b5), via openFDA; the full label on DailyMed
What do FAERS reports show for cabozantinib?
The FDA Adverse Event Reporting System holds 47,766 reports that list cabozantinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,351 are coded as a death and 9,123 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Cabozantinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other